LIST OF ACRONYMS AND ABBREVIATIONS. Table 2–1 List of Acronyms and Abbreviations Used in This Protocol Abbreviation Definition ADE Adverse device effect AE Adverse event BCVA Best corrected visual acuity CFR Code of Federal Regulations CIP Clinical Investigation Plan CIR Clinical Investigation Report CRF Case report form CTT Clinical Trial Team D Diopter DEP Deviations and evaluability plan DFU Directions for use DT1 DAILIES TOTAL1® contact lenses eCRF Electronic case report form EDC Electronic Data Capture GCP Good Clinical Practice IB Investigator’s brochure ICF Informed consent form Infuse BAUSCH+LOMB INFUSE ™ contact lenses IP Investigational product IRB Institutional review board ISO International Organization for Standardization LID Lens Identification Number LogMAR Logarithm of the minimum angle of resolution mm Millimeter MOP Manual of procedures N/A Not applicable NI Noninferiority PI Principal investigator SD Standard deviation SADE Serious adverse device effect SAE Serious adverse event SLE Slit lamp examination SOP Standard operating procedure T2B Top-2-Box US United States VA Visual acuity VAS Visual Analog Scale 3 PROTOCOL SUMMARY Investigational product type Device Study type Interventional Investigational products Test Product: DT1 contact lenses Comparator Product: Infuse contact lenses Purpose and Scientific Rationale for the Study To compare the clinical performance of DT1 contact lenses with Infuse contact lenses Objective(s) The primary objective of this study is to demonstrate noninferiority (NI) in visual acuity (VA) at distance when wearing DT1 contact lenses compared to Infuse contact lenses. Endpoint(s) Primary Effectiveness • Distance VA (logMAR) with study lenses Safety • Adverse events • Biomicroscopy findings • Device deficiencies Assessment(s) Effectiveness • Distance VA (logMAR) with habitual correction • Manifest refraction and BCVA with manifest refraction • Distance visual acuity (LogMAR) with study lenses Safety • Biomicroscopy • Adverse Events • Device deficiencies Study Design This will be a prospective, randomized, , controlled, double-masked, crossover, daily wear clinical study. Subject participation in the study will be approximately 3 weeks with 16-22 days of lens wear. DT1 (Test): 8 (-0/+3) days Infuse (Comparator): 8 (-0/+3) days Subject population Planned number of subjects enrolled/consented: ~110 Planned number of completed subjects: 100 Sites and Locations Planned number of clinical sites: ~ 8 Planned locations (initial list of locations, whic...
LIST OF ACRONYMS AND ABBREVIATIONS. Table 2–1 List of Acronyms and Abbreviations Used in This Protocol Abbreviation Definition ADE Adverse device effect AE Adverse event ARMD Age-related macular degeneration xx Xxxxxxx CI Confidence interval CRF Case report form D Diopter(s) GCP Good Clinical Practice IB Investigator’s brochure ICF Informed consent form IOL Intraocular lens IOP Intraocular pressure IP Investigational product IRB Investigational review board LASIK Laser-assisted in situ keratomileusis LRI Limbal relaxing incision mm millimeter MOP Manual of procedures PCO Posterior capsule opacification PRK Photorefractive keratectomy SAE Serious adverse event SADE Serious adverse device effect SD Standard deviation SOP Standard operating procedure SSI Secondary Surgical Intervention(s) VA Visual acuity YAG Yttrium aluminum garnet laser
LIST OF ACRONYMS AND ABBREVIATIONS. 3GPP 3rd Generation Partnership Project 5GPPP 5G infrastructure Public Private Partnership ACM Access Control Manager AP Access Point ATPC Automatic Transmit Power Control BiCMOS Bipolar Complementary Metal-Oxide Semiconductor BS Base Station CMOS Complementary Metal-Oxide Semiconductor EC European Commission EMF Electromagnetic Field FD-SOI Fully Depleted Silicon On Insulator FP7 Seventh Framework Program IC Integrated Circuit IoT Internet of Things IPC Institute for Interconnecting and Packaging Electronic Circuits IPR Intellectual Property Rights IQ or I/Q In-phase/Quadrature-phase KPI Key Performance Indicator LCP Liquid Crystal Polymer LTCC Low Temperature Cofired Ceramic LTE Long Term Evolution LTE-A Long Term Evolution Advanced M2M Machine to Machine MSE Mean Square Error mmWave Millimeter Wave PCB Printed Circuit Boards QoS Quality of Service RAN Radio Acccess Network RF Radio Frequency RRH Remote RadioHead Rx Receive SiGe Silicon Germanium SME Small Medium Enterprise SoC System on Chip STO Standardization Office TA Technical Annex Tx Transmit UE User Equipment WP Work Package
LIST OF ACRONYMS AND ABBREVIATIONS. BSC Barcelona Supercomputing Center CF Crop Forcing COD Codorniu DSS Decision Support System IRTA Institue of Agrifood Research and Technology LINKS LINKS Foundation MBD Mastroberardino MET Meteosim NAP University of Naples PAB Project Advisory Board XX Xxxxxxxxx SEM SEMIDE SYM Xxxxxxxxx UNAP University of Naples UPORTO University of Porto WP Work Package
